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IRCT20180103038199N8 IRCT 2021-07-27 Mashhad University of Medical Sciences The effect of Portulaca oleracea hydrogel on the prevention of radiotherapy-induced dermatitis Evaluation of the effectivness of hydrogel containing Purslane extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients 2021-07-23 anticipated 80 Complete https://irct.ir/trial/57260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method, the size of blocks is equal to four with two members A and B in a ratio of 1: 1. Based on the sample size, 20 blocks are numbered in a different order from 1 to 20 and a random sequence of 20 blocks is determined using the site "www.Randomaize.com", then the sequence of treatment groups A and B is determined in envelopes with number 1 Up to 80, with the inclusion of each eligible person, the envelope corresponding to the person's number is opened and the treatment group is determined, Blinding description: Due to the use of a placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell. 2-3 Radiotherapy-induced mucositis is breast-conserving cancer patients. Intervention 1: Control group: Patients undergo radiotherapy, will receive placebo hydrogel containing glycerin and green dye made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks. Intervention 2: Intervention group: Patients undergo radiotherapy, will receive hydrogel containing 2% Portulaca oleracea extract and glycerin content made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Female patients diagnosed with breast tissue cancer Age over 18 years No concomitant chemotherapy No previous radiotherapy to the chest area Minimum radiation of 50 Gy during treatment BMI 20-30 Breast conserving surgery 18 years no limit Female Existence of underlying diseases hypersensitivity to Portulaca oleracea Patients with metastatic carcinoma to the breast Inability of the patient to implement the treatment protocol L58.0, L27 Acute radiodermatitis, Localized skin eruption due to drugs and medicament Placebo Treatment - Drugs Control group: Patients undergo radiotherapy, will receive placebo hydrogel containing glycerin and green dye made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks. Intervention group: Patients undergo radiotherapy, will receive hydrogel containing 2% Portulaca oleracea extract and glycerin content made by Mashhad University of Medical Sciences. Patients will use this hydrogel twice a day (at least two hours before radiotherapy and at least two hours after radiotherapy) and topically for 6 weeks. Incidence of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG). Severity of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG). Quality of life. Timepoint: at the beginning and the end of the study. Method of measurement: Ware & Sherbourne's quality of life questionnaire. Mashhad University of Medical Sciences Approved 2021-06-19 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)